Morbid ObesitySENAPIDNCT01525472
Accelerated Aging of the Cells of Visceral Adipose Tissue in Morbid Obese Subjects
An observational study of Morbid Obesity, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Numerous epidemiological studies clearly showed the relationship between the excessive growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and other cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2012to 20 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital center
Who may be able to join
- Age between 18 and 65 y
- Social security insurance
- Candidate for bariatric surgery based on criteria established by international experts (BMI> 40 or> 35 kg / m² with comorbidities, after failure of multidisciplinary care for a period of at least 1 year)
- Patient having signed an informed consent
Who cannot join
- Subject under guardian ship, curator ship or judicial protection.
- Subject taking anti-inflammatory and / or non-steroidal drug
- Current immunosuppressive therapy or interrupted for less than six months
- malignancy or severe inflammatory disease evolving
- Positive HIV serology and / or HBV and / or HCV
- Current pregnancy
- medical or psychiatric contraindication for bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerated Aging of the Cells of Visceral Adipose Tissue in Morbid Obese Subjects: Involvement in Diseases Associated With Obesity (Viellissement accéléré Des Cellules du Tissu Adipeux viscéral Chez Les obèses Morbides: Implication Dans Les Pathologies associées à l'obésité)
Numerous epidemiological studies clearly showed the relationship between the excessive growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and other cardiovascular risk factors. However, the mechanisms contributing to the deleterious role of visceral adipose tissue remain to be elucidated. Several observations suggest that adipose tissue depots exhibit distinct metabolic and secretory capacities according to their locations. We have recently shown that visceral fat depots display higher immuno-inflammatory cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and several markers related to aging. Finally, we have shown that visceral adipocyte-derived secretions promote the endothelial cell senescence in an extent higher than subcutaneous adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon related to the location and therefore the microenvironment of adipose tissue and 2) might be responsible for an abnormal activation of proinflammatory response, favouring the development of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis, based on these observations, is that the visceral adipose tissue provides a microenvironment that promotes accelerated aging. This senescence may be responsible for the establishment of an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation capacity of progenitor cells leading to the development of obesity associated diseases.
The proposed project is a descriptive cross-sectional pathophysiological study .The aims are 1) to better define the process of senescence in human adipose tissue, 2) to precise the mechanisms and 3) to analyse the cellular and functional consequences of aging on inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for bariatric surgery will be studied. The collection of clinical and laboratory data and the collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells, progenitor cells and immuno-inflammatory cells).
This project will permit to better understand the pathogenicity associated with the excessive growth of visceral adipose tissue and may reveal new therapeutic targets to limit obesity-associated pathologies.
Read the detailed description
Main objective: The main objectives are 1) to compare the state of senescence of subcutaneous versus visceral adipose tissues and 2) to define the senescent cell populations in subcutaneous and visceral adipose tissues in morbidly obese patients.
Secondary objectives: Secondary objectives are 1) to precise whether the state of senescence is attributable to microenvironment, 2) to determine the impact of aging on cellular function, 3) to establish a link between the state of senescence of subcutaneous and visceral adipose tissues and obesity-associated pathologies.
- Conditions
- Morbid Obesity
- Keywords
- obesity, adipose tissue, angiogenesis, senecence
- Medical subject headings
- Obesity, Morbid, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the state of senescence
Per gram of tissue will be determined by counting live cells and by flow cytometry
Measured: Day 2
Determination of the total number of adipocytes
Using immunoselection/depletion technique
Measured: Day 2
Determination of the number of progenitor cells (CD34+/CD31-)
Using immunoselection/depletion technique
Measured: Day 2
Determination of the number of endothelial cells (CD34+/CD31+)
Using immunoselection/depletion technique
Measured: Day 2
Determination of the number of myeloid cells (macrophages and dendritic cells) (CD45+/CD14+)
Using immunoselection/depletion technique
Measured: Day 2
Determination of the number of T lymphocyte cells (CD45+/CD3+/CD4+ and CD45+/CD3+/CD8+)
Using immunoselection/depletion technique
Measured: Day 2
Expression level of the senescence marker SIRT-1 (Sirtuin 1)
On adipocytes and stroma-vascular cells isolated using immunoselection technique
Measured: Day2
Expression level of the senescence marker p53
On adipocytes and stroma-vascular cells isolated using immunoselection technique
Measured: Day 2
Expression level of the senescence marker Pre-Lamin A
On adipocytes and stroma-vascular cells isolated using immunoselection technique
Measured: Day 2
Determination of the number of gH2AX nuclei
Immunohistochemistry number of positive nuclei per 100 nuclei
Measured: Day 2
Determination of number of cells accumulating Lipofuscin
Immunohistochemistry number of positive nuclei per 100 nuclei
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study start13 Feb 2012
- Primary completionOct 2015
- Study completion20 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525472
- Sponsor's protocol ID
- C11-18'
- Other IDs
- 2011-A01070-41
- Acronym
- SENAPID
- Status last verified
- Aug 2021
- First submitted
- 1 Feb 2012
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gao H, Volat F, Sandhow L, Galitzky J, Nguyen T, Esteve D, Astrom G, Mejhert N, Ledoux S, Thalamas C, Arner P, Guillemot JC, Qian H, Ryden M, Bouloumie A. CD36 Is a Marker of Human Adipocyte Progenitors with Pronounced Adipogenic and Triglyceride Accumulation Potential. Stem Cells. 2017 Jul;35(7):1799-1814. doi: 10.1002/stem.2635. Epub 2017 May 18.
PubMed 28470788Esteve D, Boulet N, Volat F, Zakaroff-Girard A, Ledoux S, Coupaye M, Decaunes P, Belles C, Gaits-Iacovoni F, Iacovoni JS, Remaury A, Castel B, Ferrara P, Heymes C, Lafontan M, Bouloumie A, Galitzky J. Human white and brite adipogenesis is supported by MSCA1 and is impaired by immune cells. Stem Cells. 2015 Apr;33(4):1277-91. doi: 10.1002/stem.1916.
PubMed 25523907Briot A, Decaunes P, Volat F, Belles C, Coupaye M, Ledoux S, Bouloumie A. Senescence Alters PPARgamma (Peroxisome Proliferator-Activated Receptor Gamma)-Dependent Fatty Acid Handling in Human Adipose Tissue Microvascular Endothelial Cells and Favors Inflammation. Arterioscler Thromb Vasc Biol. 2018 May;38(5):1134-1146. doi: 10.1161/ATVBAHA.118.310797. Epub 2018 Mar 15.
PubMed 29545239Esteve D, Boulet N, Belles C, Zakaroff-Girard A, Decaunes P, Briot A, Veeranagouda Y, Didier M, Remaury A, Guillemot JC, Ledoux S, Dani C, Bouloumie A, Galitzky J. Lobular architecture of human adipose tissue defines the niche and fate of progenitor cells. Nat Commun. 2019 Jun 11;10(1):2549. doi: 10.1038/s41467-019-09992-3.
PubMed 31186409Boulet N, Briot A, Jargaud V, Esteve D, Remaury A, Belles C, Viana P, Fontaine J, Murphy L, Deon C, Guillemot M, Pech C, Veeranagouda Y, Didier M, Decaunes P, Mouisel E, Carpene C, Iacovoni JS, Zakaroff-Girard A, Grolleau JL, Galitzky J, Ledoux S, Guillemot JC, Bouloumie A. Notch activation shifts the fate decision of senescent progenitors toward myofibrogenesis in human adipose tissue. Aging Cell. 2023 Mar;22(3):e13776. doi: 10.1111/acel.13776. Epub 2023 Jan 8.
PubMed 36617688Ledoux S, Boulet N, Belles C, Zakaroff-Girard A, Bernard A, Germain A, Decaunes P, Briot A, Galitzky J, Bouloumie A. Subcutaneous Stromal Cells and Visceral Adipocyte Size Are Determinants of Metabolic Flexibility in Obesity and in Response to Weight Loss Surgery. Cells. 2022 Nov 9;11(22):3540. doi: 10.3390/cells11223540.
PubMed 36428969
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Aging of the Cells of Visceral Adipose Tissue in Morbid Obese Subjects: Involvement in Diseases Associated With Obesity (Viellissement accéléré Des Cellules du Tissu Adipeux viscéral Chez Les obèses Morbides: Implication Dans Les Pathologies associées à l'obésité)
- ClinicalTrials.gov ID
- NCT01525472
- Acronym / sponsor ID
- SENAPID / C11-18'
- Conditions
- Morbid Obesity
- Keywords
- obesity, adipose tissue, angiogenesis, senecence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 13 Feb 2012 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 20 Oct 2015 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous epidemiological studies clearly showed the relationship between the excessive growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and other cardiovascular risk factors. However, the mechanisms contributing to the deleterious role of visceral adipose tissue remain to be elucidated. Several observations suggest that adipose tissue depots exhibit distinct metabolic and secretory capacities according to their locations. We have recently shown that visceral fat depots display higher immuno-inflammatory cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and several markers related to aging. Finally, we have shown that visceral adipocyte-derived secretions promote the endothelial cell senescence in an extent higher than subcutaneous adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon related to the location and therefore the microenvironment of adipose tissue and 2) might be responsible for an abnormal activation of proinflammatory response, favouring the development of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis, based on these observations, is that the visceral adipose tissue provides a microenvironment that promotes accelerated aging. This senescence may be responsible for the establishment of an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation capacity of progenitor cells leading to the development of obesity associated diseases.
The proposed project is a descriptive cross-sectional pathophysiological study .The aims are 1) to better define the process of senescence in human adipose tissue, 2) to precise the mechanisms and 3) to analyse the cellular and functional consequences of aging on inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for bariatric surgery will be studied. The collection of clinical and laboratory data and the collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells, progenitor cells and immuno-inflammatory cells).
This project will permit to better understand the pathogenicity associated with the excessive growth of visceral adipose tissue and may reveal new therapeutic targets to limit obesity-associated pathologies.
Detailed description
Main objective: The main objectives are 1) to compare the state of senescence of subcutaneous versus visceral adipose tissues and 2) to define the senescent cell populations in subcutaneous and visceral adipose tissues in morbidly obese patients.
Secondary objectives: Secondary objectives are 1) to precise whether the state of senescence is attributable to microenvironment, 2) to determine the impact of aging on cellular function, 3) to establish a link between the state of senescence of subcutaneous and visceral adipose tissues and obesity-associated pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital center
Key inclusion criteria (4 listed)
- Age between 18 and 65 y
- Social security insurance
- Candidate for bariatric surgery based on criteria established by international experts (BMI> 40 or> 35 kg / m² with comorbidities, after failure of multidisciplinary care for a period of at least 1 year)
- Patient having signed an informed consent
Key exclusion criteria (7 listed)
- Subject under guardian ship, curator ship or judicial protection.
- Subject taking anti-inflammatory and / or non-steroidal drug
- Current immunosuppressive therapy or interrupted for less than six months
- malignancy or severe inflammatory disease evolving
- Positive HIV serology and / or HBV and / or HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the state of senescence
Time frame: Day 2
Per gram of tissue will be determined by counting live cells and by flow cytometry
Determination of the total number of adipocytes
Time frame: Day 2
Using immunoselection/depletion technique
Determination of the number of progenitor cells (CD34+/CD31-)
Time frame: Day 2
Using immunoselection/depletion technique
Determination of the number of endothelial cells (CD34+/CD31+)
Time frame: Day 2
Using immunoselection/depletion technique
Determination of the number of myeloid cells (macrophages and dendritic cells) (CD45+/CD14+)
Time frame: Day 2
Using immunoselection/depletion technique
Determination of the number of T lymphocyte cells (CD45+/CD3+/CD4+ and CD45+/CD3+/CD8+)
Time frame: Day 2
Using immunoselection/depletion technique
Expression level of the senescence marker SIRT-1 (Sirtuin 1)
Time frame: Day2
On adipocytes and stroma-vascular cells isolated using immunoselection technique
Expression level of the senescence marker p53
Time frame: Day 2
On adipocytes and stroma-vascular cells isolated using immunoselection technique
Expression level of the senescence marker Pre-Lamin A
Time frame: Day 2
On adipocytes and stroma-vascular cells isolated using immunoselection technique
Determination of the number of gH2AX nuclei
Time frame: Day 2
Immunohistochemistry number of positive nuclei per 100 nuclei
Determination of number of cells accumulating Lipofuscin
Time frame: Day 2
Immunohistochemistry number of positive nuclei per 100 nuclei
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publication: PubMed 28470788Gao H, Volat F, Sandhow L, Galitzky J, Nguyen T, Esteve D, Astrom G, Mejhert N, Ledoux S, Thalamas C, Arner P, Guillemot JC, Qian H, Ryden M, Bouloumie A. CD36 Is a Marker of Human Adipocyte Progenitors with Pronounced Adipogenic and Triglyceride Accumulation Potential. Stem Cells. 2017 Jul;35(7):1799-1814. doi: 10.1002/stem.2635. Epub 2017 May 18.
- Results publication: PubMed 25523907Esteve D, Boulet N, Volat F, Zakaroff-Girard A, Ledoux S, Coupaye M, Decaunes P, Belles C, Gaits-Iacovoni F, Iacovoni JS, Remaury A, Castel B, Ferrara P, Heymes C, Lafontan M, Bouloumie A, Galitzky J. Human white and brite adipogenesis is supported by MSCA1 and is impaired by immune cells. Stem Cells. 2015 Apr;33(4):1277-91. doi: 10.1002/stem.1916.
- Results publication: PubMed 29545239Briot A, Decaunes P, Volat F, Belles C, Coupaye M, Ledoux S, Bouloumie A. Senescence Alters PPARgamma (Peroxisome Proliferator-Activated Receptor Gamma)-Dependent Fatty Acid Handling in Human Adipose Tissue Microvascular Endothelial Cells and Favors Inflammation. Arterioscler Thromb Vasc Biol. 2018 May;38(5):1134-1146. doi: 10.1161/ATVBAHA.118.310797. Epub 2018 Mar 15.
- Results publication: PubMed 31186409Esteve D, Boulet N, Belles C, Zakaroff-Girard A, Decaunes P, Briot A, Veeranagouda Y, Didier M, Remaury A, Guillemot JC, Ledoux S, Dani C, Bouloumie A, Galitzky J. Lobular architecture of human adipose tissue defines the niche and fate of progenitor cells. Nat Commun. 2019 Jun 11;10(1):2549. doi: 10.1038/s41467-019-09992-3.
- Results publication: PubMed 36617688Boulet N, Briot A, Jargaud V, Esteve D, Remaury A, Belles C, Viana P, Fontaine J, Murphy L, Deon C, Guillemot M, Pech C, Veeranagouda Y, Didier M, Decaunes P, Mouisel E, Carpene C, Iacovoni JS, Zakaroff-Girard A, Grolleau JL, Galitzky J, Ledoux S, Guillemot JC, Bouloumie A. Notch activation shifts the fate decision of senescent progenitors toward myofibrogenesis in human adipose tissue. Aging Cell. 2023 Mar;22(3):e13776. doi: 10.1111/acel.13776. Epub 2023 Jan 8.
- Results publication: PubMed 36428969Ledoux S, Boulet N, Belles C, Zakaroff-Girard A, Bernard A, Germain A, Decaunes P, Briot A, Galitzky J, Bouloumie A. Subcutaneous Stromal Cells and Visceral Adipocyte Size Are Determinants of Metabolic Flexibility in Obesity and in Response to Weight Loss Surgery. Cells. 2022 Nov 9;11(22):3540. doi: 10.3390/cells11223540.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the state of senescence (time frame: Day 2). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01525472, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.